abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part) |
| Right: | Manufactured Drug Product (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0' vs '2.0.0-ballot' |
| Information | StructureDefinition.date | Values for date differ: '2024-12-11T13:47:08+00:00' vs '2024-12-12T01:58:44+00:00' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition | ||
| copyright | |||
| date | 2024-12-11T13:47:08+00:00 | 2024-12-12T01:58:44+00:00 |
|
| description | The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component. | ||
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | FinishedProduct | ||
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | Manufactured Drug Product | ||
| type | ManufacturedItemDefinition | ||
| url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part | ||
| version | 1.0.0 | 2.0.0-ballot |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself | |||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | SΣ | 0..1 | Identifier | Unique identifier | SΣ | 0..1 | Identifier | Unique identifier | |||||||||
| status | ?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. | ?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact. | |||||||||
| name | SΣ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name | SΣ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name | |||||||||
| manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: ?? (required) | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: ?? (required) | |||||||||
| unitOfPresentation | Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient. | Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient. | |||||||||
| manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of the item, one of several possible | Σ | 0..* | Reference(Organization) | Manufacturer of the item, one of several possible | |||||||||
| marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | |||||||||
| ingredient | Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | |||||||||
 Slices for property | SΣ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | SΣ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| text | SΣ | 1..1 | string | Plain text representation of the concept | SΣ | 1..1 | string | Plain text representation of the concept | |||||||||
| value[x] | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | |||||||||
 component | SΣC | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive | SΣC | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||
| type | SΣ | 1..1 | CodeableConcept | Product Part Type | SΣ | 1..1 | CodeableConcept | Product Part Type | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: ?? (required) | Σ | 0..* | Coding | Code defined by a terminology system Binding: ?? (required) | |||||||||
| text | Σ | 0..1 | string | Plain text representation of the concept | Σ | 0..1 | string | Plain text representation of the concept | |||||||||
| function | S | 0..* | ?? | Product Part Function Description | S | 0..* | ?? | Product Part Function Description | |||||||||
| Slices for amount | SΣ | 0..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code | SΣ | 0..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code | |||||||||
| constituent | SΣC | 1..* | BackboneElement | Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive | SΣC | 1..* | BackboneElement | Product Part Ingredient Component Function Category cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||||
| Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||
| Slices for amount | SΣ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code | SΣ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code | |||||||||
| location | SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location | SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Binding: ?? (required) | SΣ | 1..1 | Coding | Code defined by a terminology system Binding: ?? (required) | |||||||||
| text | SΣ | 0..1 | string | Plain text representation of the concept | SΣ | 0..1 | string | Plain text representation of the concept | |||||||||
| Slices for function | SΣ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this | SΣ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this | |||||||||
| hasIngredient | S | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | Reference to a resource or a concept | S | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | Reference to a resource or a concept | |||||||||
| Slices for property | SΣ | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | SΣ | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| text | SΣ | 1..1 | string | Plain text representation of the concept | SΣ | 1..1 | string | Plain text representation of the concept | |||||||||
| value[x] | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary) | A value for the characteristic | |||||||||
 component | SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | SΣ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from | |||||||||
| Documentation for this format | |||||||||||||||||